MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

Device Problems Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.(b)(6).

Event Description

On (b)(6) 2017, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Follow-up #1: date of submission 10-apr-2018.Device evaluation: the device has been returned and evaluated by product analysis on 05-apr-2018 with the following findings: a review of the black box history showed multiple call service 087 alarms.The issue was duplicated during rewind.The call service 069 failure was written to the black box as a call service 087 failure.Investigation revealed that a language corruption occurred at a component on the printed circuit board resulting in a call service alarm.Unrelated to the original complaint the display was dim with a red hue.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 7156310
• MDR Text Key: 96116354
• Report Number: 2531779-2017-29507
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 26 MO
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1